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The Procter & Gamble Company
Legal Division
1 Procter & Gamble Plaza, Cincinnati, Ohio 45202-3315 I
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September7, 1999
Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
Room l-23
12420 Parklawn Drive
Rockville, M D 20857
PETITION FOR STAY OF ACTION
The Procter & Gamble Company (“P&G”) submits this petition to request that the Commissioner
of Food and Drugs stay for six months the effective date of the final rule’ requiring that labeling for
over-the-counter (“OTC”) nasal decongestantdrug products change the name of the listed active
ingredient I-desoxyephedrineto levmetamfetamine. Under the final rule, labeling must reflect this
name change by July 30, 1999. P&G is requesting a six month extension of this date, because
unforeseen interruption in its raw material supply has left the company unable to deplete the existing
labeling stock for our Vi&s Vapor Inhaler. W ith additional time, P&G will be able to exhaust the
current label supply.
DECISION INVOLVED
On July 30, 1998, the Food and Drug Administration (“FDA”)
published a final rule
amending the final monograph for OTC nasal decongestantdrug products and requiring that labeling
change the name of the active ingredient “1-desoxyephedrine”to “levmetamfetamine. ” The name
change reflects a new United States Pharmacopeia(“USP”) monograph, which includes
levmetamfetamineas the new name for what had formerly been I-desoxyephedrine. Although both
FDA and the Drug Enforcement Administration (“DEA”)
objected to the name change, the USP
’63 Fed. Reg. 40647 (July 30, 1998) (codified at 21 C.F.R. 9 341.20)
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adopted the new name based on the recommendation of the United States Adopted Names Council and
its interpretation of International Nomenclature Name policies. 63 Fed. Reg. at 40648. FDA has
identified no public health concerns requiring the chemical name change.
In adopting the USP monograph and the name change, FDA provided for a one-year effective
date, such that labeling must reflect the new established name by July 30, 1999. FDA set this effective
date in order to allow manufacturers “sufficient time to incorporate the change during a future
manufacturing cycle. ” 63 Fed. Reg. at 40649. As explained below, P&G has prepared and obtained
new labeling; however, special circumstances have prevented P&G from using its old labeling during
the one-year period in which FDA envisioned such labeling would be used UP.~
ACTION REOUESTED
P&G requests that the FDA extend until January 30, 2000 the deadline for changing the name of
ingredient l-desoxyephedrine to levmetamfetamine in the OTC nasal decongestantmonograph. P&G
files this petition for stay of action more than 30 days after FDA’s publication of the final rule, and
requestspermission to file for good cause under 21 C.F.R. 0 10.35 (b) & (g). The need for a stay now
has only recently become apparent when P&G understood the extent and duration in the interruption of
our raw material supply. The six month extension will allow P&G to exhaust its current supply of
product labeling.
STATEMENT OF GROUNDS
I. P&G has been unable to deplete its current labeling because of an unforeseen accident at the
factory of its raw material supplier.
FDA stated when it promulgated the final rule requiring the change from ingredient ldesoxyephedrineto levmetamfetamine that it was providing a one-year effective date in order to allow
manufacturers to make the change during future manufacturing runs. 63 Fed. Reg. at 40649. P&G
moved promptly after publication of the rule to begin working on new labeling art and copy for our
Vi&s Vapor Inhaler. Unfortunately, the lone global supplier of the active ingredient, ldesoxyephedrine, suffered an explosion at its factory in August 1998 and halted all production.
Complicating this situation was the fact the that this lone supplier was also in the process of
selling their operation. P&G worked with the lone global supplier and its buyer to help them
understand the situation even as the sale of the company was progressing. The sale was completed late
December 1998. Although the new owner applied for a DEA license in early January, 1999, they did
not have DEA approval to produce product until after the effective date of the final rule. They
completed their first full production run in August 1999.
As a result, P&G has remained unable to manufacture finished product for months during the
critical period leading up to the effective date of the final rule, July 30, 1999. Absent the explosion at
our supplier’s factory, P&G would have exhaustedall our old labeling as part of our normal business
cycle, just as the FDA envisioned when assessingthe impact of the regulation. However, with the
explosion, P&G is left with a substantial stock of old labeling. Currently, we are unable to use these
old labels and they will become obsolete if P&G is not given additional time to exhaust the inventory
as our normal production resumes.
II. Good cause exists to grant the stay.
Under 21 C.F.R. fj 10.35(e), FDA shall grant a stay where: (1) the petitioner will suffer
irreparable injury without the stay; (2) the petitioner’s case is not frivolous and is brought in good
faith; (3) the petitioner has demonstrated sound public policy grounds in support of the stay; (4) public
health or other public interests do not outweigh the resulting delay. P&G satisfies each of these
criteria.
’ In this respect,P&G is in a position similar to Leiner Health Products,who filed a Petition for Stay of Action
on July 7, 1999.
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1.
P&G will suffer irreparable iqjury without the stay.
Without the stay P&G will suffer irreparable economic injury. Our inventory is worth
approximately $41,752. All of this labeling will have to be discarded if our petition is denied. P&G
has no way to recoup this loss.
2.
P&G’s petition is bona fide and pursued in good faith.
P&G’s petition is neither frivolous nor pursued in bad faith. P&G needs the extension of the
effective date of FDA’s final rule becauseof the unfortunate explosion at the factory of our raw
material supplier. P&G began work on new labeling and copy but we were simply unable to use the
existing labels we had on hand due to the shortage of raw material. P&G has only recently realized
that the supply situation would not change before the July 30, 1999 deadline. Despite our good faith
efforts with the original supplier, the DEA and the new supplier (buyer), raw material has not been
made available to us until past the effective date of the final rule.
Although we have an existing inventory of new labels to ensure P&G complies with the new rule,
we are pursuing this petition in order to eliminate the waste of $41,752 worth of old labels. This
waste would be particularly unjustified becausethe labeling change relates to a technical issue of
chemical nomenclature and not a public health concern,
3.
Granting the stay would avoid economically wasteful actions and promote the objectives FDA
sought to capture in its initial rule.
Public policy supports the grant of stay. The FDA noted in promulgating the final rule that the
costs of the rule involved were “not economically significant.” 63 Fed. Reg. at 40649. This
conclusion was based on a premise that “an effective date of 1 year . . . will provide manufactures
sufficient time to incorporate the name change during a normal manufacturing cycle.” Id. P&G’s
normal manufacturing cycle was crippled by the explosion at the manufacturing plant of our raw
material supplier. Granting P&G additional time for complying with the required name change will
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allow us sufficient time to complete a normal manufacturing cycle and will be consistent with FDA’s
own stated objective of allowing manufacturers sufficient time to incorporate the new labeling during a
normal manufacturing cycle.
Adherence to the July 30, 1999 effective date will impose costs on P&G and other companies
with no corresponding public benefit, while granting a stay will avoid costs with no public harm.
Granting the stay promotes good regulatory policy in accordancewith Executive Order 12,866 which
directs agenciesto “assess all costs and benefits of available regulatory alternatives” and “select those
approachesthat maximize net benefits. ”
4. No countervailing public health concern or other considerations require denial of P&G’s stay
request.
No public health concern or other public interest considerations compel denial of the stay. Unlike
other regulations, the final rule at issue here was driven by a technical issue of chemical nomenclature
following the USP’s adoption of a new monograph, and was not spurred by any pressing public health
concern. Both FDA and DEA opposed the name change for fear that adoption of the name
“levmetamfetamine” might encourage the diversion of legal drug products for use in the illicit
manufacture of methamphetamine. 63 Fed. Reg. at 40648. The FDA identified no public health or
public policy basis for its regulation other than the desire to track the new USP monograph.
Accordingly, no public health risk is created by allowing P&G a limited additional period of time in
which to deplete its old labeling, just as no risk was created by FDA’s initial determination to allow
companies to use the old labeling for one year following publication of the final monograph for OTC
nasal decongestants.
For the foregoing reasons, the requested stay of action should be granted.
Respectfully submitted,
Susan S. Whaley
The Procter & Gamble Company
Legal Division
1 Procter & Gamble Plaza
Cincinnati, Ohio 45202-33 15
(5 13) 983-7695